The US probe against Ranbaxy has taken a critical turn, with a congressional committee launching an investigation into the Food & Drug Administration?s (FDA) handling of allegations that Ranbaxy sold potentially adulterated medicines. According to the US media, the house energy & commerce committee disclosed late Wednesday that it wants to find out if FDA knowingly allowed unsafe and ineffective medicine to enter the US.
However, Ranbaxy said it is not aware of any congress-ional inquiry.US daily The Star-Ledger says the committee will examine Ranbaxy?s drug approvals in the US and potential violations of manufacturing regulations. The committee also will look at why FDA continued to approve medicines made by the company and allow shipments into the US while it was questioning Ranbaxy?s manufacturing processes. FDA spokeswoman Julie Zawisza declined to comment, saying the Ranbaxy case is the subject of an open federal investigation, reports said.
?If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,? said Rep John Dingell (D-Mich.), chairman of the house energy & commerce committee. ?I would like to know whether FDA officials knew about these allegations and what, if any, action was taken,? he added.
In a statement to the Bombay Stock Exchange, Ranbaxy said, ?During the past three years, FDA has gathered over 200 random samples of various products marketed by the company in the US. These products have been independently tested by the USFDA and were found to be complying with all the specifications as per the filing. Ranbaxy is in the process of submitting supporting documentation for its ANDA applications to DOJ and believes that this will demonstrate no wrong doing on its part,? the statement said.
On Thursday, FE had reported that Ranbaxy is likely to be hurt if FDA asks it to re-submit the abbreviated new drug applications (ANDA) for generic drugs, which await approvals in the US, in the backdrop of investigations.
On July 3, in a motion filed at the US district court in Maryland, Federal prosecutors had disclosed that they were investigating Ranbaxy Laboratories for allegedly falsifying records that resulted in the production and sale of generic medicines in the US that did not meet US quality standards. Officials at a Ranbaxy plant in northern India fabricated test data to show their pills met FDA standards and attempted to conceal the ruse from FDA inspectors, prosecutors charged.
In February 2007, federal agents raided Ranbaxy?s North American headquarters in Plainsboro and a manufacturing facility in New Brunswick. The raid was prompted, in part, by problems uncovered in FDA inspections in 2006 at the company?s plant in Paonta Sahib. Late last year, Ranbaxy voluntarily recalled 73 million doses of a generic version of the pain pill Neurontin.
